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MALAYSIA: MDA REPEALS CIRCULAR EXEMPTING COVID-19 TEST KITS FROM THE COMPLIANCE ASSESSMENT PROCESS - APRIL/MAY 2024

MALAYSIA: MDA REPEALS CIRCULAR EXEMPTING COVID-19 TEST KITS FROM THE COMPLIANCE ASSESSMENT PROCESS - APRIL/MAY 2024

  • 2024-05-07 09:28:59

The Medical Device Authority (MDA) announced the cancellation of the Circular exempting the registration of Covid-19 Test Kits from the Compliance Assessment Process by the Compliance Assessment Body (CAB). The MDA Circular No. 1/2022 states the exemption of the compliance assessment process by the Compliance Assessment Body (CAB) under Section 7 of the Medical Devices Act 2012 (Act 737) for the registration of COVID-19 test kits under Section 5 of Act 737 either for self-use or for professional use.

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HONG KONG: A COMPREHENSIVE GUIDE TO THE NEW MD111 SUPPLEMENTARY INFORMATION SHEET– MARCH/APRIL 2024

HONG KONG: A COMPREHENSIVE GUIDE TO THE NEW MD111 SUPPLEMENTARY INFORMATION SHEET– MARCH/APRIL 2024

  • 2024-04-08 07:44:40

Last February 19, 2024, Hong Kong Medical Device Division has published a Supplementary Information Sheet (MD111) to strengthen procurement strategy with the Hospital Authority (HA). HA procured devices seeking to be listed under Medical Device Administrative Control System can provide supplementary information through this form for regulatory authorities’ consideration.

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MALAYSIA: MDA/GD/0066: IMPORTATION OF MEDICAL DEVICE FOR PERSONAL USE –  MARCH/APRIL 2024

MALAYSIA: MDA/GD/0066: IMPORTATION OF MEDICAL DEVICE FOR PERSONAL USE – MARCH/APRIL 2024

  • 2024-04-03 09:46:01

The Medical Device Authority (MDA) published new Guidance Document, on "MEDICAL DEVICE FOR PERSONAL USE", on January 30, 2024. This document serves as guidance for individuals who intend to bring any medical devices into Malaysia (referred as "import") for the purpose of personal use.
This guidance document specifies the requirements for the importation of personal use medical devices. This document applies to all home use medical devices that fall within the definition of a medical device, as defined in MDA/GD/0006: Definition of Medical Device, including in vitro diagnostic (IVD) medical devices. Not all medical device can fall under the category of personal use medical device.

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MALAYSIA: MDA/GD/0067: POST MARKET INFORMATION EXCHANGE FOR ASEAN MEMBER STATES –MARCH/APRIL 2024

MALAYSIA: MDA/GD/0067: POST MARKET INFORMATION EXCHANGE FOR ASEAN MEMBER STATES –MARCH/APRIL 2024

  • 2024-04-03 09:34:09

The Medical Device Authority (MDA) published new Guidance Document, on “POST MARKET INFORMATION EXCHANGE FOR ASEAN MEMBER STATES”, on January, 2024. This document serves as guidance on exchange of post market information among AMS.
In order to maintain patient safety and public health, it is necessary that all medical devices that are placed in the market meet appropriate standards of safety, quality and performance, and that they are used safely.

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